FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083318 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Cow Colostrum improves platelet count 
Scientific Title of Study   Beneficial Effect of Cow Colostrum on Platelet Count – A Multicenter Global Clinical Trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1319-7181  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Khartode 
Designation  Chief Dietitian and Clinical Researcher 
Affiliation  Vishwaraj Hospital 
Address  OPD No 6, Department of Dietetics and Nutrition, Ground Floor,Vishwaraj Hospital, Near Loni station, Pune- Solapur Road, Loni kalbhor, Pune- 412201

Pune
MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietitian and Clinical Researcher 
Affiliation  Vishwaraj Hospital 
Address  OPD No 6, Department of Dietetics and Nutrition, Ground Floor,Vishwaraj Hospital, Near Loni station, Pune- Solapur Road, Loni kalbhor, Pune- 412201

Pune
MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swati Khartode 
Designation  Chief Dietitian and Clinical Researcher 
Affiliation  Vishwaraj Hospital 
Address  OPD No 6, Department of Dietetics and Nutrition, Ground Floor,Vishwaraj Hospital, Near Loni station, Pune- Solapur Road, Loni kalbhor, Pune- 412201

Pune
MAHARASHTRA
412201
India 
Phone  9767133699  
Fax    
Email  opd@vrhpune.com  
 
Source of Monetary or Material Support  
Vishwaraj Hospital Near Loni station, Pune- Solapur Road, Loni kalbhor, Pune, Maharashtra, India Pin - 412201  
 
Primary Sponsor  
Name  Vishwaraj Hospital 
Address  Vishwaraj Hospital, Near Loni station, Pune- Solapur Road, Loni kalbhor, Pune- 412201  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
APS Biogroup  APS BioGroup Main Offices and Manufacturing Facilities: 2235 South Central Ave Phoenix, AZ 85004 US  
SG dairy Australia  South Gippsland Dairy Pty. Ltd. PO Box 26, Korumburra. Victoria, 3950 
 
Countries of Recruitment     United Arab Emirates
Australia
India
Nigeria
United Kingdom
United States of America  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swati Khartode  Vishwaraj Hospital   OPD No 6, Department of Dietetics and Nutrition, Ground Floor,Vishwaraj Hospital, Near Loni station, Pune- Solapur Road, Loni kalbhor, Pune, Maharashtra, India Pin- 412201
Pune
MAHARASHTRA 
9767133699

opd@vrhpune.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEER’S Vishwaraj Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R70-R79||Abnormal findings on examination of blood, without diagnosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cow Colostrum Food Supplement powder   Cow Colostrum Food supplement 10 gms (2 teaspoons) with water BD for 3 months  
Comparator Agent  NONE Control group will not receive any cow colostrum supplement or placebo  Not applicable. Control group will not receive any cow colostrum supplement or placebo 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  To be eligible for the study, Subjects must meet the following criteria:
1. Male or female subjects of age group
10-18 years and 18-75 years
2. Confirmed clinical diagnosis of low platelet count by using complete blood count test (CBC)
 
 
ExclusionCriteria 
Details  Subjects with any of the following conditions will be excluded from the study:
1. Subjects who is having Lactose Intolerance (Allergic to milk).
2. Those who are ‘Pure Vegan’ (Not taking any animal product including milk and milk products).
3. Acute or Chronic Kidney Disease
4. Pregnant females and Lactating mothers 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To check increasing trend of platelet count   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Early recovery from the symptoms if any  3 months 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Study Rationale:

Since the time immemorial, man has sought some alternative methods to enhance and improve the immune system of human body in order to fight against diseases. Historically, Ayurvedic physicians have used bovine colostrum for therapeutical application in Asia, particularly in India for thousands of years. Increased awareness of the diet - health relationship in many countries has stimulated a trend in nutrition science whereby more attention is given to the health effects of individual foods. (Seth, R., & Das, A. (2011). Colostrum is the initial milk secreted by bovine during parturition and the first few days after birth. Colostrum is a gift of nature used to protect the newborn’s immune system and provides passive immunity against pathogens. The presence of bioactive components such as insulin-like growth factor I and II (IGF-I and IGF-II), lactoferrin, lysozyme, lactoperoxidase, and immunoglobulin make the colostrum active against many pathogens. It is also active against Herpes simplex virus type-I (HSV-I), Human Immuno-deficiency virus-I (HIV-I), and human cytomegalovirus. Immunoglobulins are considered an important bioactive component in colostrum, and it contains high levels of immunoglobulin G (Ig G). Immuno-supplementation with bovine milk antibodies has been shown to provide local protection to the gastrointestinal tract against disease.  (Tripathi, V., & Vashishtha, B. (2006).

The world-wide trend towards the development of health-promoting foods offers interesting opportunities for applications which contain specific antibody ingredients derived from immunized cows. It is anticipated that colostrum based preparations may have remarkable potential to contribute to human health care as part of health promoting diet and as an alternative or a supplement to the medical treatment of specified human diseases. Bovine colostrum virtually contain all compounds of human cellular and humoral immune defense. (Seth, R., & Das, A. (2011).

Thus, it has been observed that there is wide study on effect of bovine colostrum on gastro-intestinal diseases, HIV patients, athletes, also cancer patients but lack in study of effect of cow colostrum immunoglobulins on low platelet count induced by viral fever, cancer treatment.

All over the world milk and milk products of cow has been eating since Ancient time, it is easily available worldwide, easily digested with good absorption rate. Also colostrum has no side effect like any medicine as it is a food supplement, so there is a need of Study to check the Effect of Immunoglobulins present in Cow Colostrum in low platelet count subjects to increase the platelet count, enhance the immune system and for early recovery rate. In this study we are using cow colostrum which Lactose intolerance people also can eat it but we will exclude those patients. Also these supplements have been prepared by Freeze Dried method so there is no loss of Immunoglobulins.

Major components of cow colostrum:

The most important components of cow colostrum can basically be broken down into two major categories: Immune system factors and Growth factors.

Immunoglobulins (A, D, E, G and M) - the most abundant of the immune factors found in colostrum.

Lactoferrin - an antiviral, anti-bacterial, anti-inflammatory, iron- binding protein with therapeutic effects in many diseases.

Proline-Rich Polypeptide (PRP)

Growth Factors:

Epithelial growth factor (EgF)

Insulin-like growth factor-I and II (IGF-1 and IGF-II) Fibroblast growth factor (FgF)

Platelet-derived growth factor (PDGF) Transforming growth factors A & B (TgA and B) Growth hormone (GH)


 
Close